RESEARCH TRIANGLE PARK, N.C. - Fennec Pharmaceuticals (NASDAQ:FENC) Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company with a market capitalization of $160 million and an impressive "GREAT" financial health rating according to InvestingPro, announced today that its partner Norgine Pharmaceuticals Ltd. has received final draft guidance from the National Institute for Health and Care Excellence (NICE) endorsing PEDMARQSI for the prevention of cisplatin-induced hearing loss in young cancer patients. PEDMARQSI, a sodium thiosulfate formulation, is the first therapy approved in the European Union and the United Kingdom (TADAWUL:4280) for this indication.
The recommendation follows clinical evidence from two Phase 3 trials, which showed PEDMARQSI could reduce the risk of hearing loss by about 50% in children treated with cisplatin. Hearing loss is a common side effect of cisplatin, a chemotherapeutic agent, leading to significant lifelong challenges for pediatric cancer survivors.
This development is particularly significant as there have been no prior pharmacological interventions to prevent such ototoxicity. PEDMARQSI's approval is seen as a vital step in addressing this unmet medical need.
Fennec entered into an exclusive licensing agreement with Norgine in March 2024, allowing Norgine to commercialize PEDMARQSI in Europe, Australia, and New Zealand. The agreement included an upfront payment of approximately $43 million to Fennec, with potential additional milestone payments and royalties on net sales. This deal has contributed to Fennec's remarkable 278% year-over-year revenue growth and industry-leading 93.5% gross profit margin, as reported by InvestingPro.
Jeff Hackman, CEO of Fennec Pharmaceuticals, expressed his support for Norgine's efforts to collaborate with NICE and highlighted the importance of ototoxicity prevention in the cancer treatment process.
PEDMARQSI is also the only U.S. Food and Drug Administration (FDA) approved therapy to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic, solid tumors. It has been endorsed by the National Comprehensive Cancer Network (LON:NETW)® for the Adolescent and Young Adult (AYA) population.
The safety and efficacy of PEDMARQSI have been established across two clinical studies, COG ACCL0431 and SIOPEL 6, with a focus on survival and reduction of ototoxicity.
Despite the positive outcomes, the treatment does carry risks, including hypersensitivity reactions and electrolyte imbalances, necessitating monitoring and management of patients.
Fennec's PEDMARQSI has received Orphan Drug Exclusivity in the U.S. and Pediatric Use Marketing Authorization in Europe, which includes extended periods of data and market protection.
This announcement is based on a press release statement from Fennec Pharmaceuticals Inc.
In other recent news, Fennec Pharmaceuticals reported notable growth in its third-quarter earnings, with an emphasis on the expansion of PEDMARK, a therapy designed to mitigate cisplatin-associated hearing loss. The company's net product sales rose to $22 million for the first nine months of 2024, surpassing the total sales of the previous year. Additionally, Fennec maintained a strong cash position, projecting the ability to fund operations well into 2026.
Recent developments include the preparation for PEDMARQSI's launch in Germany and the U.K. in 2025, and a fully enrolled PEDMARK trial in Japan with results expected in the same year. However, Fennec also noted an increase in general and administrative expenses to $6.1 million, influenced by stock compensation and litigation costs.
CEO Jeff Hackman expressed optimism about growth prospects, pointing to academic endorsements and market expansion. The company is also exploring business development opportunities, including entering the Japanese market, while managing ongoing IP litigation. These recent developments provide insight into Fennec's strategic initiatives and financial performance.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.